Verified March 2017 by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Sponsor:

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

ClinicalTrials.gov Identifier:

NCT01671865

First Posted: August 24, 2012

Last Update Posted: March 3, 2017

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This research study is being done to study changes in muscle imaging over time in people with facioscapulohumeral muscular dystrophy (FSHD). Whole-body magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS) will be used to evaluate skeletal muscle in study participants. This research is being done to assess how changes in muscle imaging correspond to muscle strength and function. Qualified participants will be asked to complete 5 study visits over 21 months. Each visit will include muscle strength and function testing in addition to the MRI/MRS scan. The investigators plan to use MRI and MRS in developing outcome measures that can be used in future clinical trials for FSHD.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:

12 Years and older (Child, Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Sampling Method:

Non-Probability Sample

Study Population

This study will include people with facioscapulohumeral muscular dystrophy confirmed through genetic testing.

Criteria

Inclusion Criteria:

Ability to give written informed consent for study participation (a parent or guardian will be asked to provide informed consent for participants younger than 18 years old)

Confirmed diagnosis of FSHD through genetic testing (participants will be asked to provide copies of genetic testing results)

Exclusion Criteria:

Any contraindication to MRI scanning

Inability to complete a physical examination, including strength measurements

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01671865